Nociplastic Pain in Patients With Chronic Shoulder Pain

NCT ID: NCT05481710

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-18

Study Completion Date

2025-01-10

Brief Summary

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The aim of this study was to investigate predictors of nociplastic shoulder pain. Factors of psychological distress, functionality, fitness, quality of life, quality of sleep, functioning of the parasympathetic system, and lifestyle will be examined. Patients with nociplastic pain will be identified using the classification system proposed by the IASP.

Detailed Description

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The main part of the study will include patients with chronic shoulder pain who visit the Hand Surgery-Upper Limb and Microsurgery Department of the General Hospital KAT. The measurements will be performed in one session. Once participants have been informed of the purpose and procedure of the study and given written consent, they will complete their demographics and a series of questionnaires and questions about their pain history. They will then be examined by a doctor and finally subjected to dynamometry, a functional test and two quantitative sensory tests.

Conditions

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Chronic Shoulder Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Nociplastic Pain Criteria

All participants will be assessed with the specific nociplastic pain criteria

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients (men and women) with chronic shoulder pain (lasting more than 3 months, 3/10 Numeric Pain Rating Scale),
* aged 18-65 years
* mentally able to follow instructions or
* healthy volunteers
* aged 18-65
* who do not experience pain and have not received analgesic medication in the last trimester.

Exclusion Criteria

* referred shoulder pain from different primary sources of pain (eg shoulder pain in women with mastectomy or stroke),
* pain manifested by movements in the neck,
* shoulder arthroplasty or fractures or dislocation of the shoulder, -
* diagnosis of chronic pain syndrome such as fibromyalgia, chronic fatigue syndrome, chronic regional pain syndrome, cancer diagnosis, osteoporosis, rheumatic inflammatory diseases,
* use of medication for neurological/psychiatric disorders,
* the presence of gastrointestinal or renal disease
* taking medication that may affect the assessment results, such as calcium channel blockers that could alter HRV,
* pregnancy or childbirth before 1 year will be excluded from the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Paraskevi Bilika

OTHER

Sponsor Role lead

Responsible Party

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Paraskevi Bilika

Study Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Paraskevi N. Bilika

Role: PRINCIPAL_INVESTIGATOR

University of Thessaly

Eleni V. Kapreli

Role: STUDY_DIRECTOR

University of Thessaly

Locations

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Clinical Exercise Physiology and Rehabilitation Laboratory

Lamia, Central Greece, Greece

Site Status

KAT Attica General Hospital

Athens, , Greece

Site Status

Countries

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Greece

References

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Miller AB. The costs and benefits of breast cancer screening. Am J Prev Med. 1993 May-Jun;9(3):175-80.

Reference Type BACKGROUND
PMID: 8347369 (View on PubMed)

Related Links

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https://www.ijclinicaltrials.com/index.php/ijct/article/view/545

Psychometric properties of quantitative sensory testing focusing on healthy and patients with shoulder pain: a systematic review protocol

Other Identifiers

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5

Identifier Type: -

Identifier Source: org_study_id

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